JP2003270239A - Implement and method for separation of living-body sample - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a separation implement for simplifying a sampling- operation of a living-body sample so as to reduce inspection costs. <P>SOLUTION: The separation implement is provided with a living-body-sample sampling means 2 for housing the sampled living-body sample, a filtration means 21 for passing a prescribed component in the sampled living-body sample, a separation-component housing means 3 for being inserted into and passed through the sampling means 2 and for housing the prescribed component passing the filtration means 21, and a backflow preventive means 5 for preventing the prescribed component housed in the housing means 3 from flowing backwards to the side of the sampling means 2 via the filtration means 21. The living-body sample is sampled by the sampling means 2, the housing means 3 is inserted into, and passed through, the sampling means 2, the prescribed component in the living-body sample passes the filtration means 21, the preventive means 5 blocks up a flow channel between the housing means 3 and the sampling means 2 so as to prevent the prescribed component from flowing backwards, and the prescribed component in the living-body sample is separated so as to be housed in the housing means 3. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a biological sample separation device and its separation method, and more particularly to a blood separation device for separating collected blood into blood cells and plasma or serum and its separation method.

[0002]

2. Description of the Related Art Conventionally, in clinical tests, generally,
A certain qualified person or specialized technician such as a doctor, a nurse, a clinical laboratory technician, etc. collects a biological sample by blood sampling or the like, and performs a predetermined test based on the collected biological sample.

[0003]

However, in the conventional form of biochemical examination, in order to collect a biological sample, the person to be inspected is a doctor, a nurse, a clinical technologist, or the like who is qualified or specialized. It was necessary to go to a hospital or a testing center where a technician is located, or, on the contrary, a certain qualified person or a specialized technician to go to the inspected person's whereabouts. Therefore, it takes a lot of time and effort to collect a biological sample, which causes an increase in inspection cost.

Further, since the live blood changes rapidly with the passage of time, there are variations in the accuracy of inspection. Therefore, it is necessary to develop a testing device that can obtain a more accurate test result by separating blood immediately after blood collection.

Further, in order to simplify the work of collecting the biological sample, a method of collecting the biological sample by the test subject himself / herself has been carried out, but this method is effective only for some test items. However, there was a problem that it could not be applied to other inspection items.

The present invention has been made in view of the above circumstances, and a biological sample separating instrument and a biological sample separating instrument which can simplify the operation of collecting a biological sample, improve the inspection accuracy, and reduce the inspection cost. It provides a separation method.

[0007]

According to the present invention, a biological sample collecting means for containing a collected biological sample, a filtering means for allowing a predetermined component in the collected biological sample to pass therethrough, and the biological sample collecting means to be inserted thereinto. It is possible, and the separated component storage means for storing the predetermined component that has passed through the filtration means and the predetermined component stored in the separated component storage means flow back to the biological sample collection means side through the filtration means. And a backflow preventing means for preventing the above-mentioned, collecting a biological sample in the biological sample collecting means, and inserting the separated component storage means into the biological sample collecting means, a predetermined component in the biological sample is filtered. After passing through the means, the backflow prevention means blocks the flow path between the separated component storage means and the biological sample collecting means to prevent backflow of the predetermined component, and the predetermined component of the biological sample is separated. Success Characterized in that it is configured to be separated housed in the housing means.

[0008] Preferably, the present invention comprises a blood collection container for containing the collected blood, a filtration membrane for allowing passage of plasma or serum in the collected blood and for preventing passage of blood cells,
A cylindrical body that can be inserted into the blood collection container and that can store the plasma or serum that has passed through the filtration membrane, and the plasma or serum stored in the cylinder flows back to the blood collection container side through the filtration membrane. With a sealing lid to prevent the blood is collected in the blood collection container, and the cylinder is inserted into the blood collection container,
After plasma or serum in the blood has passed through the filtration membrane,
The sealing lid closes the flow path between the cylindrical body and the blood collection container, prevents the reverse flow of plasma or serum, and collects blood cells in the blood collection container,
It is characterized in that it is configured to separately store plasma or serum in a cylinder.

Further, more preferably, a diluted solution is placed in the blood collection container.

Further, the blood collection container has the same diameter as the sample cup for the biochemical analyzer, a screw portion is provided at the upper end, the filtration membrane is provided at the lower end of the cylindrical body, and the cylindrical body has a cap piston. Is capped, the cap piston is provided with a knob portion that can be screwed into the screw portion, and a mandrel portion extending from the knob portion into the cylindrical body, and the sealing lid is provided at a lower end portion of the mandrel portion. Collecting blood in the blood collecting container, inserting the tubular body into the blood collecting container, and screwing the knob portion to the screw portion, plasma or serum in the blood passes through the filtration membrane, and then the seal is made. A lid seals the lower end of the cylinder,
The backflow of the plasma or serum is prevented, and the plasma or serum is separately housed in the cylinder and the blood cells are respectively housed in the blood collection container.

Further, the tubular body has an upper end portion into which the cap piston can be fitted, and a main body portion separable from the upper end portion and engageable with the blood collection container, and the knob portion is the above-mentioned. When the threaded portion of the blood collecting container is screwed, the movement of the body portion is restrained by locking the body portion with the blood collecting container, and the upper end portion is separated from the body portion.

Further, the sealing lid is detachably attached to the lower end portion of the mandrel portion and can be fitted to the lower end portion of the cylindrical body, and the screwed state of the knob portion and the screw portion of the blood collecting container is released. Then, when the cap piston is pulled out, the sealing lid is separated from the lower end portion of the mandrel portion, and the lower end portion of the cylindrical body is kept sealed.

According to the present invention, a step of inserting the separated component accommodating means into the biological sample collecting means for collecting the biological sample and accommodating a predetermined component in the biological sample into the separated component accommodating means side through a filtering means. , After storing the predetermined component in the separated component storage means, by blocking the flow path between the separated component storage means and the biological sample collecting means by the backflow prevention means, to prevent the backflow of the predetermined component, And a step of separately storing the predetermined component in the separate component storing means.

Further, a tubular body is inserted into a blood sampling container for collecting blood, and a knob portion of a cap piston capped on the tubular body is screwed into a screw portion of the blood sampling container to obtain plasma or blood in the blood. A step of accommodating serum in the cylinder through a filtration membrane, and accommodating the plasma or serum in the cylinder,
A step of closing a flow path between the tubular body and the blood collection container by a sealing lid, preventing backflow of the plasma or serum, and separately storing plasma or serum in the tubular body and blood cells in the blood collection container; It is characterized by having.

According to the above-mentioned invention, the work of collecting a biological sample can be simplified and the inspection cost can be reduced.
In addition, since the biological sample can be completely separated, it is possible to suppress the change with time of the sample and perform a highly accurate test.

[0016]

BEST MODE FOR CARRYING OUT THE INVENTION A biological sample separation instrument and a separation method therefor according to an embodiment of the present invention will be described below with reference to the drawings.

1 to 13 show the case where blood is used as a biological sample. The blood separation instrument 1 in this case is provided with a blood collection container 2, a cylinder body 3 that can be inserted into the blood collection container 2, a cap piston 4 that can be attached to the cylinder body 3, and a lower end of the cap piston 4. Before use, as shown in FIG. 1, the upper end opening of the blood collection container 2 is sealed with a cap 6 via a packing 7 before use.

As best shown in FIGS. 2 and 3, the blood collection container 2 is made of a transparent material and has a cylindrical shape, and a screw portion 8 is formed on the outer surface at the upper end thereof, and the inner surface is formed. A locking portion 9 is provided so as to project. Further, an inverted conical bottom portion 10 is formed at the lower end portion of the blood collection container 2, and a cylindrical leg portion 11 is formed around the bottom portion 10. The leg 11
Has the same outer diameter as the sample cup used in the blood analysis test, and preferably has slit grooves 12 formed in the vertical direction at the opposite ends of the lower end thereof. Further, in the blood collection container 2, as shown in FIG. 1, a required amount of the diluted solution 1 such as 500 mm ³ is used.
3 is entered in advance.

As best shown in FIGS. 4 and 5, the tubular body 3 is made of a transparent material and has a cylindrical shape, and an enlarged diameter portion 14 is formed at the upper end thereof. The enlarged diameter portion 14 is connected to the main body portion 16 through the thin wall portion 15, and the main body portion 1
A stopper portion 17 is provided so as to project in the vertical direction at the intermediate portion of 6. Further, a reduced diameter portion 18 is formed at the lower end of the cylindrical body 3, and a locking projection portion 19 is formed on the inner surface of the reduced diameter portion 18. Further, an outer flange portion 20 is formed at the lower end of the reduced diameter portion 18, the lower end opening of the outer flange portion 20 is covered with a filtration membrane 21, and the filtration membrane 21 allows passage of plasma or serum in blood. To allow the passage of blood cells.

A cover 22 made of silicone rubber is attached to the outer periphery of the reduced diameter portion 18 (see FIG. 1). As best shown in FIGS. 6 and 7, a protrusion 23 is formed on the outer periphery of the upper end portion of the cover 22, and the lower end portion 24 is gradually expanded in diameter, so that the protrusion 23 and the lower end portion 24 are formed. The outer diameter of is slightly larger than the outer diameter of the main body 16. Further, a peripheral groove 25 is formed on the inner surface of the cover 22, and the outer flange portion 20 is fitted into the peripheral groove 25 to prevent the cover 22 from falling off the reduced diameter portion 18. It has become.

The cap piston 4 is shown in FIGS. 8 and 9.
As best shown in FIG.
And a mandrel portion 27 concentric with the knob portion 26 and extending downward. A cylindrical space 28 into which the expanded diameter portion 14 of the tubular body 3 can be fitted is formed at the inner upper end portion of the knob portion 26, and the lower portion thereof is threaded and can be screwed into the screw portion 8. Has become. The mandrel portion 27 has a lower end portion 29.
Is formed in a pin shape, and the sealing lid 5 is detachably attached to the lower end portion 29 (see FIG. 1). The sealing lid 5 is made of silicone rubber and, as best shown in FIGS. 10 and 11, has a substantially columnar shape with a lower end portion formed in an outer brim shape, and a step portion 31 is formed along the outer periphery. ing. Also,
The sealing lid 5 is formed with a groove 32 that can be inserted into and removed from the lower end 29 of the mandrel portion 27.

The blood separation method according to the embodiment of the present invention will be described below with reference to FIGS. 1 and 12 and 13.

The cap 6 and the packing 7 are removed from the blood collecting container 2, and the person to be inspected pierces the finger or the like of his / her hand with a blood collecting needle, and a small amount, for example, 1 to 2 drops of blood is put into the blood collecting container 2. Collect. The collected blood is gradually separated into blood cells and plasma or serum in the diluted solution 13, the blood cells start to coagulate and precipitate in the diluted solution 13, and the plasma or serum floats in the diluted solution 13. Begin to. In this state, as shown in FIG. 12, the cylindrical body 3 capped with the cap piston 4 is attached to the blood collection container 2
The knob 26 is fitted into the inside and the knob 26 is screwed onto the screw 8. Initially, the tubular body 3 also rotates together with the knob portion 26, but when the locking portion 9 is locked to the stopper portion 17, the rotation of the tubular body 3 is restricted and the thin portion 15 is broken by twisting. As a result, the tubular body 3 is separated into the main body portion 16 and the expanded diameter portion 14. Then, when the picking portion 26 is further rotated, the upper end portion 33 of the main body portion 16 enters the inner portion of the expanded diameter portion 14 of the space 28 and is pressed downward by the inner surface of the top portion 34 of the picking portion 26. As a result, the cylindrical body 3 is further lowered. As the tube 3 descends, plasma or serum floating in the diluted solution 13 passes through the filtration membrane 21 and moves to the tube 3 side, but the blood cells pass through the filtration membrane 21. It cannot be made and remains in the blood collection container 2. At this time, since the outer diameters of the projecting portion 23 and the lower end portion 24 of the cover 22 are larger than the outer diameter of the main body portion 16 of the tubular body 3, the tubular body 3 is lowered in a state of being in close contact with the inner surface of the blood collection container 2. To do. Therefore, in the process of inserting the tube body 3 into the blood collection container 2,
There is no possibility that the blood in the blood collection container 2 or the diluted solution 13 will leak to the outside through the gap between the blood collection container 2 and the cylindrical body 3. Then, when the knob portion 26 is screwed to the screw portion 8 to the lowermost portion, the sealing lid 5 becomes the reduced diameter portion 1
8, the flow path between the blood collection container 2 and the cylindrical body 3 is sealed by the sealing lid 5, and the state of being separated into blood cells and plasma or serum is reliably maintained.

Next, in this state, the blood separating instrument 1 is transported to the inspection place, where the picking portion 26 is rotated,
Remove. At this time, the step portion 31 of the sealing lid 5 is locked to the locking projection portion 19, the sealing lid 5 is separated from the lower end portion 29 of the mandrel portion 27 and remains in the reduced diameter portion 18, Since only the picking portion 26 and the mandrel portion 27 are removed, there is no risk of blood cells and plasma or serum being mixed. After that, the tubular body 3 is pulled out from the blood collection container 2 and the blood collection container 2
The blood cells inside and the plasma or serum inside the cylindrical body 3 are analyzed by an analyzer, respectively, and a predetermined test is performed. At this time, since the blood collection container 2 has the same outer diameter as the sample cup, the blood cells in the blood collection container 2 can be set as they are in the analyzer without transferring to the sample cup, improving the working efficiency, The amount of blood collected can be reduced.

As described above, since blood can be immediately separated into blood cells and plasma or serum immediately after blood collection and can be transported to the examination place as it is, hemolysis during transport, blood coagulation and the like are prevented. can do. Therefore, the blood can be stored well and the test accuracy can be improved. Further, since a centrifuge is not used for separating blood, a small amount of blood can be collected, and the same test items as those normally required can be tested.

In the above-mentioned embodiment, the cap piston 4 is screwed to the blood collection container 2, but if the connecting method is detachable and can maintain airtightness, it can be screwed. The connection method is not limited to this, and may be another connection method such as providing a taper.

In the description of the above embodiment, the test subject himself collects blood by self-collection, but in the present invention, a qualified person such as a doctor uses a syringe to collect blood. Needless to say, it is possible to carry out general blood sampling.

Further, in the above embodiment, the case where blood is used as the biological sample has been described, but the present invention can be carried out on biological samples other than blood, such as urine, stool, pleural effusion, ascites, and saliva. is there.

[0029]

As described above, according to the present invention, the work of collecting a biological sample can be simplified and the inspection cost can be reduced. In addition, since the biological sample can be completely separated, it exhibits various excellent effects such as suppressing the change with time of the sample and enabling highly accurate inspection.

[Brief description of drawings]

FIG. 1 is a cross-sectional view showing a blood separation device according to an embodiment of the present invention.

FIG. 2 is a side view showing the blood collection container according to the embodiment of the present invention.

3 is a cross-sectional view taken along the line AA of FIG.

FIG. 4 is a side view showing a cylindrical body according to the embodiment of the present invention.

5 is a sectional view taken along line BB of FIG.

FIG. 6 is a side view showing the cover according to the embodiment of the present invention.

FIG. 7 is a sectional view taken along line CC of FIG.

FIG. 8 is a side view showing the cap piston according to the embodiment of the present invention.

9 is a cross-sectional view taken along the line DD of FIG.

FIG. 10 is a side view showing a sealing lid according to the present invention.

11 is a sectional view taken along line EE of FIG.

FIG. 12 is a cross-sectional view showing the operation of the blood separation device according to the embodiment of the present invention.

FIG. 13 is a cross-sectional view showing the operation of the blood separation device according to the embodiment of the present invention.

[Explanation of symbols]

1 blood separation device 2 blood collection container 3 cylinder 4 Cap piston 5 Sealing lid 8 screw part 9 Locking part 13 diluted solution 14 Expanded part 16 Main body 17 Stopper 18 Reduced diameter part 21 Filtration membrane 26 Picking part 27 Mandrel part 29 Lower end

Claims (8)

[Claims] 1. A biological sample collecting means for accommodating the collected biological sample, a filtering means for passing a predetermined component in the collected biological sample, and a fitting means which can be inserted into the biological sample collecting means. Separation component storage means for storing the passed predetermined component, and backflow prevention means for preventing the predetermined component stored in the separation component storage means from flowing back to the biological sample collecting means side through the filtering means. Comprising, collecting a biological sample in the biological sample collecting means, when the separated component accommodation means is inserted into the biological sample collecting means, after a predetermined component in the biological sample has passed through the filtering means,
The backflow prevention means blocks the flow path between the separated component storage means and the biological sample collecting means to prevent backflow of the predetermined component, and the predetermined component of the biological sample is separated and stored in the separated component storage means. A biological sample separation instrument characterized by being configured as described above. 2. A blood collection container that stores the collected blood, a filtration membrane that allows passage of plasma or serum in the collected blood and prevents passage of blood cells, and is insertable into the blood collection container, A cylindrical body capable of accommodating the plasma or serum that has passed through the filtration membrane, and a sealing lid that prevents the plasma or serum accommodated in the cylindrical body from flowing back to the blood collection container side through the filtration membrane. , Collecting blood in the blood collecting container, and inserting the cylinder into the blood collecting container, plasma or serum in the blood after passing through the filtration membrane, the sealing lid is the cylinder and the blood collecting container Block the flow path between and to prevent the reverse flow of plasma or serum,
A biological sample separation instrument, which is configured to separately store blood cells in a blood collection container and plasma or serum in a cylinder. 3. The biological sample separation device according to claim 2, wherein a diluted solution is placed in the blood collection container. 4. The blood collection container has the same diameter as the sample cup, a screw portion is provided at an upper end portion thereof, the filtration membrane is provided at a lower end portion of the cylindrical body, and a cap piston is attached to the cylindrical body. The cap piston includes a knob portion that can be screwed into the screw portion, and a mandrel portion that extends from the knob portion into the cylindrical body, and the sealing lid is provided at a lower end portion of the mandrel portion. When blood is collected, the tubular body is fitted into the blood collection container, and the knob portion is screwed into the screw portion, plasma or serum in the blood passes through the filtration membrane, and then the sealing lid is attached to the tubular body. The structure according to claim 2 or 3, wherein the lower end of the body is hermetically sealed to prevent backflow of the plasma or serum, and to separately store plasma or serum in the cylinder and blood cells in the blood collection container. The biological sample separation device described. 5. The tubular body has an upper end portion into which the cap piston can be fitted, and a main body portion separable from the upper end portion and engageable with the blood collection container, and the picking portion includes the blood sampling portion. When the threaded portion of the container is screwed, the movement of the body portion is restrained by locking the body portion to the blood sampling container, and the upper end portion is separated from the body portion. 4. The biological sample separation device according to item 4. 6. The sealing lid is detachably attached to a lower end portion of the mandrel portion and can be fitted into a lower end portion of the cylindrical body, and releases a screwed state between the knob portion and a screw portion of the blood collection container. Then
The biological sample separation according to claim 5, wherein when the cap piston is pulled out, the sealing lid is detached from the lower end of the mandrel portion and holds the lower end of the cylindrical body in a sealed state. Equipment. 7. A step of inserting the separated component storing means into the biological sample collecting means for collecting the biological sample, and storing a predetermined component in the biological sample on the separated component storing means side through a filtering means, After accommodating the predetermined component in the separated component accommodating means, the backflow preventing means closes the flow path between the separated component accommodating means and the biological sample collecting means to prevent backflow of the predetermined component, And a step of separating and storing the components in the separated component storing means. 8. A tube body is inserted into a blood collection container for collecting blood, and a knob portion of a cap piston attached to the cylinder body is screwed into a screw portion of the blood collection container to obtain plasma in the blood or A step of accommodating serum in the cylinder through a filtration membrane, and after accommodating the plasma or serum in the cylinder, closing a flow path between the cylinder and the blood collection container with a sealing lid,
And a step of preventing backflow of the plasma or serum and separately storing the plasma or serum in the cylinder and the blood cells in the blood collection container, respectively.